The present invention generally relates to medical devices, systems, and methods, particularly for reducing hyperdynamic facial wrinkles. Embodiments of the invention include devices, systems, and methods for applying cooling to dermal tissues so as to selectively remodel one or more target tissues along and/or below an exposed surface of the skin. Embodiments of the present invention may be employed for a variety of cosmetic conditions, for example, by inhibiting undesirable and/or unsightly effects on the skin such as lines, wrinkles, and cellulite dimples. Further embodiments may find use for a wide range of medical indications. For example, the remodeling of the target tissue may achieve a desired change in its behavior or composition.
The desire to reshape various features of the human body to either correct a deformity or to improve one's appearance is common. A growing number of cosmetic surgery procedures are performed annually.
Many procedures change the appearance of the skin by reducing lines and wrinkles and typically involve injecting fillers into the skin or stimulating collagen production. Pharmacologically based therapies for wrinkle alleviation and other cosmetic applications have recently gained in popularity. Botulinum toxin type A (BOTOX®) is an example of such a pharmacologically based therapy. BOTOX® is typically injected into the facial muscles to inhibit muscle contraction, resulting in temporary enervation or paralysis of the facial muscles. Once the muscle is disabled, the movement contributing to the formation of the undesirable wrinkle is temporarily eliminated. Another example of a pharmaceutical cosmetic treatment is mesotherapy, where a cocktail of homeopathic medication, vitamins, and/or drugs approved for other indications is injected into the skin to deliver healing or corrective treatment. Various cocktails are intended to effect body sculpting and cellulite reduction by dissolving adipose tissue or resurface skin via collagen enhancement.
There are also non-pharmacologically based cosmetic treatments. For example, endermology is a mechanical therapy utilizing vacuum suction to stretch or loosen fibrous connective tissues which may cause the dimpled appearance of cellulite.
While BOTOX® and mesotherapies may temporarily reduce lines and wrinkles, reduce fat, or provide other cosmetic benefits, they are not without their drawbacks. Particularly, there are dangers associated with the injection of a known toxic substance or an unknown or untested cocktail into a patient. Additionally, while the effects of endermology are not known to be potentially dangerous, they are brief and only mildly effective.
In light of the above, it would be desirable to provide medical devices and methods that provide a non-toxic, minimally invasive treatment for tissue with minor or no side effects. Medical devices, systems, and methods utilizing a cryogenic approach to treating tissue, particularly for cosmetic defects such as wrinkles, excess fat, and cellulite, have been proposed. These medical devices, systems, and methods may be used in lieu of or compliment known pharmacologically or non-pharmacologically based cosmetic therapies. Ideally, they should allow the injection of toxins and harmful cocktails to be minimized or avoided while providing similar or improved cosmetic results. Recovery time from therapy, i.e., patient “down-time,” may also be reduced because these procedures may be performed percutaneously, with only local or no anesthetic, with minimal or no cutting of the skin, no need for suturing or other closure methods, no extensive bandaging, and limited or no bruising or other factors contributing to extended patient recovery. Additionally, cryogenic treatments are also desirable since they may be used in the treatment of other cosmetic and/or dermatological conditions (and potentially for other target tissues), particularly where the treatments may be provided with greater accuracy and control, less collateral tissue injury and/or pain, and greater ease of use.
Some examples of cryotherapy systems include those described in U.S. Pat. Nos. 5,647,868, 6,277,116, 6,858,025, and 7,083,612 as well as U.S. Patent Application Publication No. 2004/0215294 A1 (patented).
More references that may be of interest include U.S. Pat. Nos. 5,334,181, 6,032,675, 6,706,037 and 5,334,181 and “A model for the time dependent three-dimensional thermal distribution within iceballs surrounding multiple cryoprobes”: Rewcastle et al; Medical Physics, Vol. 28, No. 6, June 2001; and “Laboratory Evaluation of Ice Formation around a 3-mm Accuprobe”: Saliken et al; Cryobiology 32, 285-295 (1995).
Various devices for treatment of motor nerves are currently being developed. For example, some devices treat motor nerves of the face using heat applied by a radiofrequency probe (RF). The treatment also involves the use of electrical stimulation to identify specific treatment locations, followed by a treatment at the identified location with RF energy. While this procedure appears promising, in certain situations, the procedure may be challenging to perform. It may be painful, may require patient sedation, may be time consuming, and may have side effects. Furthermore, it has been shown that heat applied to nerves may lead to spurious regrowth and neuroma formation. Therefore, using cryotherapy through microneedles inserted using anatomical landmarks for targeting the treatment area may provide a more clinically viable procedure with local anesthetic and no permanent damage to nerves and benign side effects.
Therefore, given the challenges of current technology, a need exists for improved devices, systems, and methods, particularly for treating wrinkles of the face. At least some of these objectives will be met by the present invention.